C-FLEX POLAR HEAD POSITNER
Received Mar 12, 2025 · Event occurred Feb 27, 2025
Report 3010216206-2025-00003 · MDR key 21586843
Device
Generic name
C-flex Head Positioning System
Manufacturer
Baxter Healthcare CorporationModel number
A-70710Catalog number
A-70710
Lot number
N/A
Product problems
- Positioning Failure
- Positioning Failure
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE HEAD POSITIONER IS DESIGNED TO POSITION AND SUPPORT THE PATIENT¿S HEAD IN A VARIETY OF SURGICAL PROCEDURES INCLUDING, BUT NOT LIMITED TO SPINE SURGERY. THESE DEVICES ARE INTENDED TO BE USED BY HEALTHCARE PROFESSIONALS WITHIN THE OPERATING ROOM SETTING. ALLEN C-FLEX WAS RECEIVED BY BAXTER. UPON INSPECTION, IT WAS FOUND THAT THE LOWER PIVOT POINT OF THE C-FLEX WAS NOT HOLDING POSITION. IT WAS DETERMINED THAT THE INTERNAL PARTS OF PIVOT WERE RUSTED AND NEEDED TO BE REPLACED. BASED ON THIS INFORMATION, NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. ALTHOUGH THERE WAS NO REPORTED INJURY WITH THIS EVENT, IF THE REPORT OF C-FLEX NOT HOLDING ITS POSITION WERE TO RECUR, IT COULD POTENTIALLY CAUSE SERIOUS INJURY OR DEATH. THEREFORE BAXTER IS REPORTING THIS EVENT.
Description of Event or Problem
BAXTER RECEIVED A REPORT STATING THAT THE C-FLEX WILL NOT HOLD ITS POSITION. THE DEVICE WAS LOCATED AT THE ACCOUNT AND OCCURRED BEFORE USE. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.
Additional Manufacturer Narrative
CORRECTION: NEW INFORMATION WAS PROVIDED CONFIRMING THAT THE CORRECT MODEL NUMBER OF THE FAULTY DEVICE IS A-70710 WITH SERIAL NUMBER (B)(6). THE HEAD POSITIONER IS DESIGNED TO POSITION AND SUPPORT THE PATIENT¿S HEAD IN A VARIETY OF SURGICAL PROCEDURES INCLUDING, BUT NOT LIMITED TO SPINE SURGERY. THESE DEVICES ARE INTENDED TO BE USED BY HEALTHCARE PROFESSIONALS WITHIN THE OPERATING ROOM SETTING. ALLEN C-FLEX WAS RECEIVED BY BAXTER. UPON INSPECTION, IT WAS FOUND THAT THE LOWER PIVOT POINT OF THE C-FLEX WAS NOT HOLDING POSITION. IT WAS DETERMINED THAT THE INTERNAL PARTS OF PIVOT WERE RUSTED AND NEEDED TO BE REPLACED. BASED ON THIS INFORMATION, NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. ALTHOUGH THERE WAS NO REPORTED INJURY WITH THIS EVENT, IF THE REPORT OF C-FLEX NOT HOLDING ITS POSITION WERE TO RECUR, IT COULD POTENTIALLY CAUSE SERIOUS INJURY OR DEATH. THEREFORE, BAXTER IS REPORTING THIS EVENT.
Description of Event or Problem
BAXTER RECEIVED A REPORT STATING THAT THE C-FLEX WILL NOT HOLD ITS POSITION. THE DEVICE WAS LOCATED AT THE ACCOUNT AND OCCURRED BEFORE USE. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.